Colgate® Optic White Beauty™ Radiant™ Toothpaste

Colgate Optic White Beauty Radiant by

Drug Labeling and Warnings

Colgate Optic White Beauty Radiant by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE OPTIC WHITE BEAUTY RADIANT- sodium monofluorophosphate paste, dentifrice 
Mission Hills S.A de C.V

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Optic White Beauty™ Radiant™ Toothpaste

Active ingredient

Sodium monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 6 to 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
• children under 6 years: do not use unless directed by a dentist or physician

Inactive ingredients

propylene glycol, calcium pyrophosphate, PVP, PEG/PPG-116/66 copolymer, PEG-12, glycerin, flavor, hydrogen peroxide, sodium lauryl sulfate, silica, tetrasodium pyrophosphate, sodium saccharin, disodium pyrophosphate, sucralose, BHT

Some people may experience tooth sensitivity or gum discomfort when using whitening products. This discomfort is temporary and not harmful. If you experience more than mild tooth sensitivity, stop use and consult your dentist.

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

RADIANT™

WHITENS INSIDE & OUT
FOR A RADIANT SMILE

Colgate®

OPTIC
WHITE
BEAUTY™

ANTICAVITY FLUORIDE TOOTHPASTE
ENAMEL SAFE
ICY MINT

NET WT 3.0 OZ (85 g)

COLGATE OPTIC WHITE BEAUTY RADIANT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-400
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	398.3 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
POVIDONE K15 (UNII: E54VE15114)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-400-63	85 g in 1 TUBE; Type 0: Not a Combination Product	12/20/2016
2	NDC: 65954-400-16	1 in 1 CARTON	12/20/2016
2		21.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/20/2016

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019

Document Id: 8f26abde-80bf-47a8-b0fa-333c7e0e6418

34390-5

Set id: 664b0168-5e28-4bc9-b8e0-b7019c4aa855

Version: 2

Effective Time: 20190418